Sun recalled product from US last month

Voluntarily initiated by the company through a letter to USFDA last month under 'Class-II' classification

Sun Pharmaceutical’s subsidiary Caraco Pharmaceutical Laboratories recalled some lots of venlafaxine hydrochloride extended-release tablets from the US market after the product failed to meet certain specifications.

According to a notification by the US Food and Drug Administration, the recall of 26,530 units of 30-count bottles and 14,597 units of 90-count bottles was voluntarily initiated through a letter to the regulator last month under a Class-II classification. It is used for major depressive disorder.

"Stability results found the product did not meet the drug release dissolution specifications," US FDA said in its notification.

Tablet dissolution is a standardised method for measuring the rate of drug release from a dosage form.

The recalled drug bottles were distributed by Caraco Pharmaceutical Laboratories Ltd in USA, while manufactured at Halol plant in Gujarat by Sun Pharmaceutical Industries.

A class II recall is a situation in which the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.